Researchers at the University of California, San Francisco, have announced active recruitment for a clinical trial investigating external trigeminal nerve stimulation (eTNS) as a novel intervention for children presenting with symptoms of both Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD). This innovative study aims to evaluate the device’s effectiveness and safety in reducing elevated symptoms commonly associated with these conditions.
In this article:
- What changed?
- How does trigeminal nerve stimulation work?
- Key trial details
- Frequently Asked Questions (FAQ)
- Conclusion
- Disclaimer
- Source Link
What changed?
The clinical trial, being conducted in partnership with the University of California, San Francisco, has initiated enrolment. This marks a significant step toward exploring alternative interventions for ASD and ADHD, particularly targeting pediatric patients who may struggle with traditional therapies. The focus of this trial is examining external trigeminal nerve stimulation using a novel device and comparing it to a sham stimulation to establish efficacy across different patient cohorts.
For clinicians, device manufacturers, and regulatory professionals tracking innovations in medical device therapies, this trial could pave the way for future medical applications addressing comorbid psychiatric and neurodevelopmental symptoms.
How does trigeminal nerve stimulation work?
Trigeminal nerve stimulation involves the external application of electrical impulses to the trigeminal nerve, which is located in the forehead area and plays a key role in sensory processing. The device used in this study delivers specific stimulation parameters designed to interact with neural circuits associated with attention, hyperactivity, and other behavioral symptoms. According to existing research, such interventions may modulate brain activity to produce therapeutic effects over time.
While this mechanism holds promise, ongoing studies are essential to validate the physiological and psychological impacts, especially in pediatric populations. The current study is a critical component of expanding evidence-based utilization of trigeminal nerve stimulation technology for targeted symptom management.
Key trial details
The clinical trial is evaluating two groups of participants:
- Active device group: Participants will use the active trigeminal nerve stimulation device under controlled conditions.
- Sham device group: Participants will receive placebo-like stimulation designed for comparison purposes.
Sponsors: The study is sponsored by the University of California, San Francisco, implying rigorous oversight and adherence to medical device regulations.
Conditions studied: The primary focus remains on children diagnosed with ASD and ADHD, with outcomes measured by symptom severity and behavioral improvement.
Status: Currently recruiting participants, reflecting early-phase research that requires collaborative medical and parental engagement.
For detailed trial information, visit the official ClinicalTrials.gov page linked below.
Frequently Asked Questions (FAQ)
Q1: Who qualifies for this trial?
A: Recruitment is focused on children diagnosed with both Autism Spectrum Disorder and ADHD. Specific inclusion criteria may apply.
Q2: What is sham stimulation?
A: Sham stimulation mimics the appearance and feel of the active device without delivering real therapeutic electrical impulses. It helps researchers determine device efficacy by comparison.
Q3: Is trigeminal nerve stimulation FDA-approved?
A: While related devices may have clearance for certain applications, this particular intervention for ASD and ADHD is investigational and undergoing clinical evaluation.
Conclusion
The ongoing clinical trial at UCSF represents a promising exploration into the viability of external trigeminal nerve stimulation as a therapeutic option for children with ASD and ADHD. Industry professionals, regulators, and clinical teams are encouraged to monitor developments in this space to evaluate potential impacts on future medical device therapies.
Disclaimer
This article is for informational purposes and is not intended as legal advice. Medical device professionals should consult with regulatory experts for specific guidance.
Source Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07214545?term=medical+device